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NCT02300506 Clinical Trial

Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

Malignant Glioma Clinical Trial

Official title:
Post-Marketing Surveillance of Long-Term Observation of Gliadel Wafer-Investigation of Vital Prognosis in Patients With High Grade Glioma

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02300506
Other study ID # GLI02T
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 10, 2014
Est. completion date July 10, 2016

Study information
Verified date August 2017
Source Eisai Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

The objective of this study is to determine the survival status of patients enrolled in study GLI01S (all-case observational study).

Recruitment information / eligibility
Status Completed
Enrollment 507
Est. completion date July 10, 2016
Est. primary completion date July 10, 2016
Accepts healthy volunteers No
Gender All
Age group N/A and older
Eligibility Inclusion criteria:

- Malignant Glioma, patients enrolled in study GLI01S.

Exclusion criteria:

- Corresponding to contraindication of Gliadel.

- Not applicable to indications of Gliadel.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• No intervention

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Eisai Co., Ltd.

Country where clinical trial is conducted

Japan, 

Outcome
Type Measure Description Time frame Safety issue
Primary Survival rate Survival rate of subjects measured up to 3 year after implantation Up to 3 years
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